Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tandemact

Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets · Abschnitt 4.8 · PDF-Seite 10

HOS-115649 · Präparat HOS-094329

Description of selected adverse reactions 1 Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancyto-penia may occur. These are in general reversible upon discontinuation of treatment. 2 In very rare cases mild hypersensitivity reactions may develop into serious reactions with dyspnoea, fall in blood pressure and sometimes shock. Hypersensitivity reactions of the skin may occur as itching, rash, and urticaria. Cross allergenicity with sulphonylureas, sulphonamides or related substances is possible. 3 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported. These reactions include anaphylaxis, angioedema, and urticaria. 4 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic medicinal products. 5 Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy. 6 Elevation of liver enzymes may occur. In very rare cases, impairment of liver function (e.g. with cholestasis and jaundice) may develop, as well as hepatitis which may progress to liver failure. 7 A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration. A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).

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